Metabolic and Vascular Effects of Statins in Untreated Dyslipidemic Diabetic Patients

NCT00854503 | Completed Phase 3

• 1 other identifier: 131/08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes (T2D), because of impaired glucose regulation and consequent hyperglycemia, promotes the development of coronary heart disease. Secondary dyslipidemia is often associated with T2D and enhances the risk of cardiovascular complications. HMG-CoA reductase inhibitors (statins) are selectively administrated for the treatment of dyslipidemia, leading to a significant reduction of cardiovascular risk. More recently, revisions to guidelines have established a lower therapeutic LDL cholesterol goal for diabetic patients, requiring the administration of higher dose of statin. However, it is unclear whether high dose statin therapy could affect glycemic control in diabetic patients. Moreover, data regarding the effects of statins on insulin-resistance and endothelial function are controversial.

Conditions

Type 2 Diabetes; Diabetic Dyslipidemia

Keywords

Statins administration in diabetic dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Glucose tolerance assessed by HbA1c and fasting glucose

  1, 6, 12 months

Secondary Outcomes (1)

• insulin-resistance assessed by clamp. Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.

  1, 6, 12 months.

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

Simvastatin 20 mg/day

Drug: Simvastatin

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin 20 mg/day

Drug: Rosuvastatin

Interventions

Simvastatin DRUG

20 mg/day in one oral administration

Simvastatin

Rosuvastatin DRUG

20 mg/day in one oral administration.

Rosuvastatin

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes in good glycemic control, treated with metformin alone.
• Untreated dyslipidemia.
• BMI \<30.

You may not qualify if:

• History of cancer.
• History of cardiovascular diseases.
• Any other acute or cronic illness which requires administration of steroids or other drugs able to interfere with glucose metabolism.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Rome Tor Vergata

Rome, 00133, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Simvastatin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 12, 2011

Record last verified: 2011-01

Locations

IT (1)